MAUDE Adverse Event Report: AESCULAP AG TC BABY-CRILE-WOOD NDL HLDR SERR 150MM; GENERAL SURGICAL INSTRUMENTS

Model Number BM013R

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the product tc baby-crile-wood ndl hldr serr 150mm.Specifically, it was reported that the needle holder has broken.There was no patient harm reported.Additional information has been requested but not yet received as of this report.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation report: general information up to now (date of this report), the product is not available for investigation, but a picture was provided by the customer.Consequences for the patient according to the available information, there were no negative consequences for the patient.Failure description based on the provided picture, one of the tungsten carbide fell off the working end.Investigation only the provided picture is available for investigation, no details of the damaged area are visible.Batch history review the traceability of articles without batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer (backtrack).In addition, the raw materials, semi-finished parts, etc.Used for the order are documented in the manufacturing history records (dhr - device history records).This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.Conclusion and root cause without the product, an exact cause cannot be determined at this moment.Due to the constant monitoring of the compliance with our quality standards, as matters stand, a production or material defect can most likely be excluded.Therefore, the root cause of the error is most probably usage related.For further investigations, the product is required for examination.Rationale according to the quality standard, a material defect and production error can be excluded.A usage related error cannot be excluded, e.G.Due to improper handling or an overload situation.For further investigations, the product is required for examination.Corrective action a capa is not necessary.

Manufacturer Narrative

Investigation report: general information: up to now (date of this report), the product is not available for investigation, but a picture was provided by the customer.Consequences for the patient: according to the available information, there were no negative consequences for the patient.Failure description: based on the provided picture, one of the tungsten carbide fell off the working end.Investigation: only the provided picture is available for investigation, no details of the damaged area are visible.Batch history review: the traceability of articles without batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer (backtrack).In addition, the raw materials, semi-finished parts, etc.Used for the order are documented in the manufacturing history records (dhr - device history records).This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.Conclusion and root cause: without the product, an exact cause cannot be determined at this moment.Due to the constant monitoring of the compliance with our quality standards, as matters stand, a production or material defect can most likely be excluded.Therefore, the root cause of the error is most probably usage related.For further investigations, the product is required for examination.Rationale: according to the quality standard, a material defect and production error can be excluded.A usage related error cannot be excluded, e.G.Due to improper handling or an overload situation.For further investigations, the product is required for examination.Corrective action: a capa is not necessary.

• Brand Name: TC BABY-CRILE-WOOD NDL HLDR SERR 150MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10075381
• MDR Text Key: 192386377
• Report Number: 9610612-2020-00171
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BM013R
• Device Catalogue Number: BM013R
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 05/27/2020; 05/27/2020
• Supplement Dates FDA Received: 06/15/2020; 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1